Senior Manager, Regulatory Documentation and Operations
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Job Description
Senior Manager managing regulatory documentation and operations for Pulmovant's innovative therapies. Requires extensive regulatory experience with FDA and global submissions.
Responsibilities:
- Able and willing to do hands on document formatting and regulatory publishing.
- Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements.
- Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving.
- Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy.
Requirements:
- BA/BS degree required with 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs
- Knowledge of FDA submission expectations is required. Additional experience with ex-US is preferred.
- Must be solution oriented.
- Must be able to handle all aspects of regulatory operations (document and submission processing)
- Must have solid experience using Word and PDF files utilizing Veeva RIM and DocuBridge systems
- Have successfully completed IND and/or NDA/BLA submissions activities. Preferred if also handled medical device submissions and post-approval activities.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
- Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
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